Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Phase 3

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00048425
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2002-10-31
• Study First Submitted QC: 2002-11-01
• Study First Posted: 2002-11-04
• Study Completion: 2004-12
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-14
• Last Update Posted: 2006-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age.
• The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics.
• It is allowable for the patients to be treated with IV inotropes and vasodilators.

Exclusion Criteria

The following criteria would exclude the patient from study:

• invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization),
• rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate),
• severe ventricular outflow obstruction,
• angina,
• hypotension,
• uncorrected hypokalemia,
• CNS (e.g. stroke, TIA),
• respiratory (e.g. COPD, intubated patients, oral,
• intravenous or intramuscular steroids),
• renal insufficiency (e.g. increased serum creatinine, dialysis),
• hepatic impairment (e.g. significant increase in liver enzymes),
• decompensation from active infection and acute bleeding (e.g. severe anemia).
• Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions.
• Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.

Trial Locations

Locations (166)

Cardiovascular Associates/Office of Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Cardiology, P.C. Research; 🇺🇸 Birmingham, Alabama, United States

University Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Oracle Research-The Heart Center; 🇺🇸 Huntsville, Alabama, United States

Providence Hospital Heart Failure Clinic; 🇺🇸 Mobile, Alabama, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Sarver Heart Center - University of Arizona Health Science; 🇺🇸 Tucson, Arizona, United States

Central Arkansas Veterans Healthcare System; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Central Cardiology Medical Center; 🇺🇸 Bakersfield, California, United States

Scroll for more (156 remaining)